 The Food and Drug Administration (FDA) today ordered the recall of the male enhancement supplement Prolactis because it contains an undeclared drug ingredient. Lab analysis has found that Prolactis contains Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). This makes Prolatis' an unapproved drug. The Prolactis label does not disclose this ingredient.
Sildenafil is the active ingredient in Viagra. Sildenafil's analogue, Sulfoaildenafil, may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
The product subject to the recall was manufactured prior to August 9, 2010. The FDA is encouraging patients to report any side effects they suffer as a result of using Prolactis. Side effects can be reported to the FDA online HERE.
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